Denali Therapeutics Inc.

Denali Therapeutics Inc. has entered into a definitive agreement to sell its Rare Pediatric Disease Priority Review Voucher (PRV) for $195 million. The PRV was awarded by the FDA following the approval of AVLAYAH™ for Hunter syndrome. The proceeds from this sale will be used to advance Denali's pipeline of treatments for lysosomal storage disorders and neurodegenerative diseases. The deal is subject to standard closing conditions, including regulatory review.

Denali Therapeutics Inc. announced a definitive agreement to sell its Rare Pediatric Disease Priority Review Voucher (PRV) for gross proceeds of $195 million. The PRV was awarded by the FDA in March 2026 following the accelerated approval of AVLAYAH , the first FDA-approved biologic specifically designed to cross the blood-brain barrier. The company stated that these proceeds will strengthen its financial flexibility and accelerate the advancement of its broad clinical pipeline for lysosomal storage disorders and neurodegenerative diseases.

Denali Therapeutics Inc. held its annual meeting on June 3, 2026, with 86.96% of outstanding common stock represented. Stockholders elected three Class III directors: Jennifer Cook, David Schenkein, M.D., and Ryan Watts, Ph.D., to serve until the 2029 annual meeting. Additionally, the appointment of Ernst & Young LLP as the independent registered public accounting firm for fiscal year 2026 was ratified, and the advisory vote to approve executive compensation was passed.

Biogen and Denali Therapeutics announced that their Phase 2b LUMA study evaluating BIIB122 (DNL151) in early-stage Parkinson's disease failed to meet its primary or secondary endpoints. As a result, the companies will discontinue further development of BIIB122 for idiopathic Parkinson's disease. Despite the clinical outcome, exploratory biomarker endpoints demonstrated significant LRRK2 kinase inhibition, and the drug was generally well tolerated. Denali will independently continue the Phase 2a BEACON study for BIIB122 in individuals with Parkinson's disease who are carriers of a pathogenic LRRK2 variant, with data expected in the first half of 2027.

Denali Therapeutics reported a net loss of $(128.4) million, or $(0.69) per share, for Q1 2026, an improvement from $(133.0) million, or $(0.78) per share, in Q1 2025. The company's cash and cash equivalents increased to $387.6 million as of March 31, 2026, significantly boosted by $200.0 million in funding from a revenue participation right agreement following the US FDA's accelerated approval of AVLAYAH. Total liabilities increased to $339.9 million due to this new liability. Additionally, Takeda notified Denali of its decision to terminate the PTV:PGRN collaboration agreement in April 2026, leading Denali to regain full rights to DNL593.

Denali Therapeutics announced the FDA approval and U.S. commercial launch of AVLAYAH™ (tividenofusp alfa-eknm) for Hunter syndrome, marking the first medicine to leverage the transferrin receptor to cross the blood-brain barrier. The company reported a Q1 2026 net loss of $128.4 million, an improvement from $133.0 million in Q1 2025. Denali also highlighted progress in its clinical pipeline, including dosing the first patient with OTV-enabled DNL628 for Alzheimer's disease and advancing DNL593 for FTD-GRN after regaining full rights from Takeda.

Denali Therapeutics announced the FDA approval of AVLAYAH (tividenofusp alfa-eknm) for Hunter syndrome, marking the first medicine to utilize the transferrin receptor to cross the blood-brain barrier. The company has successfully launched AVLAYAH in the U.S., with the first patients already receiving commercial treatment. Denali also reported progress across its clinical pipeline, including dosing the first patient with DNL628 for Alzheimer's disease and advancing DNL593 for FTD-GRN after regaining full rights. For the first quarter of 2026, the company reported a net loss of $128.4 million and maintained a strong cash position of approximately $1.05 billion.

Denali Therapeutics received written notice from Takeda Pharmaceutical Company Limited regarding its decision to terminate the Collaboration Agreement for DNL593 (PTV:PGRN), a program for co-development and co-commercialization. The termination, driven by strategic considerations and not related to efficacy or safety data, will become effective in 60 days, reverting all rights in the DNL593 program to Denali and eliminating further financial obligations to Takeda.